News Archive

EMA - update on shortages of antibiotics in the EU

2nd February 2023

EMA - update on shortages of antibiotics in the EU EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met on Thursday to discuss the progress made and to agree on the next steps in the coordinated response to the ongoing shortages of antibiotic medicines containing amoxicillin (alone and in combination with clavulanic acid) in the EU. The MSSG is made up of representatives from EMA, the European Commission and the Heads of Medicines Agencies (HMA).

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FDA - Dosage and Administration Section of Labelling for Human Prescription Drug and Biological Products — Content and Format

2nd February 2023

Dosage and Administration Section of Labelling for Human Prescription Drug and Biological Products — Content and Format Open for Comment

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FDA - Format and Content of a REMS Document Guidance for Industry for Comment

2nd February 2023

Open for Comment

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ICH - ICH E2B(R3) Q&As Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has reached Step 4 of the ICH Process.

2nd February 2023

The ICH Secretariat is pleased to announce that as of 17 January 2023, the updated ICH E2B(R3) Q&As Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has reached Step 4 of the ICH Process.

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ICH - Quality Risk Management Q9(R1) Adopted

2nd February 2023

Final version adopted on 18th January 2023.

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ICH - The ICH M13A draft Guideline presentation available now on the ICH website

2nd February 2023

The ICH M13A draft Guideline presentation available now on the ICH website

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ICH - Training on Module I - Introduction to E2B(R3): Electronic Transmission of Individual Case Safety Reports

2nd February 2023

The ICH Secretariat is pleased to announce the publication of Module I - Introduction to E2B(R3): Electronic Transmission of Individual Case Safety Reports Training Video.

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ICH - Training on Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Product

2nd February 2023

The ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 4 of the ICH Process on 16 November 2022. Following the adoption of this Guideline, a Step 4 Introductory Training Presentation has been developed by the Q13 Expert Working Group.

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MHRA - Changes to completed paediatric studies guidance text

2nd February 2023

MHRA have made changes made to the Completed paediatric studies guidance text and suggested a new cover letter on their website.

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MHRA - Fees Consultation Outcome

2nd February 2023

MHRA - Fees Consultation Outcome

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